TABLE OF CONTENTS Drug development takes over ten years from the definition of the problem and identification of drug target to market approval from FDA. The process typically costs over $800 million (including the cost of failed prototypes) with the majority of the costs incurred during human clinical testing of the drug. Figure 4.8a shows the average time for each stage of development along with the average cost for each stage of drug development. Figure 4.8b shows, in slightly greater detail, the relative ratio in distribution of costs of drug R&D across various functional stages of development.
The functional segments of the value chain for drug development are outlined schematically in Figure 4.9 (and also discussed in Chapter 1) and the stages for each functional segment of the value chain are discussed in greater detail in the following sections.
A drug development project often starts with the identification of a disease problem that is lacking adequate treatment (a medical need ) and the discovery of a pathological mechanism that appears to influence the disease, its symptoms, or its progression. An example would be an initial idea to develop a treatment for Alzheimer s disease, as the drugs currently available are not adequate. A little research...
